Medical device balloon

ABSTRACT

A balloon catheter having a balloon formed at least in part of a blend of a first polymeric material having a first Shore durometer hardness, and at least a second polymeric material having a second Shore durometer hardness less than the Shore durometer hardness of the first polymeric material. The balloon of the invention has enhanced softness and flexibility due to the presence of the second polymeric material, and a lower than expected compliance. In a presently preferred embodiment, the balloon is formed of a blend of polymeric materials comprising polyether block amides.

This application is a continuation of application Ser. No. 09/451,902.filed Dec. 1, 1999 now U.S. Pat. No. 6,620,127.

BACKGROUND OF THE INVENTION

The invention relates to the field of intravascular catheters, and moreparticularly to a balloon catheter.

In percutaneous transluminal coronary angioplasty (PTCA) procedures, aguiding catheter is advanced until the distal tip of the guidingcatheter is seated in the ostium of a desired coronary artery. Aguidewire, positioned within an inner lumen of an dilatation catheter,is first advanced out of the distal end of the guiding catheter into thepatient's coronary artery until the distal end of the guidewire crossesa lesion to be dilated. Then the dilatation catheter having aninflatable balloon on the distal portion thereof is advanced into thepatient's coronary anatomy, over the previously introduced guidewire,until the balloon of the dilatation catheter is properly positionedacross the lesion. Once properly positioned, the dilatation balloon isinflated with liquid one or more times to a predetermined size atrelatively high pressures (e.g. greater than 8 atmospheres) so that thestenosis is compressed against the arterial wall and the wall expandedto open up the passageway. Generally, the inflated diameter of theballoon is approximately the same diameter as the native diameter of thebody lumen being dilated so as to complete the dilatation but notoverexpand the artery wall. Substantial, uncontrolled expansion of theballoon against the vessel wall can cause trauma to the vessel wall.After the balloon is finally deflated, blood flow resumes through thedilated artery and the dilatation catheter can be removed therefrom.

In such angioplasty procedures, there may be restenosis of the artery,i.e. reformation of the arterial blockage, which necessitates eitheranother angioplasty procedure, or some other method of repairing orstrengthening the dilated area. To reduce the restenosis rate and tostrengthen the dilated area, physicians frequently implant anintravascular prosthesis, generally called a stent, inside the artery atthe site of the lesion. Stents may also be used to repair vessels havingan intimal flap or dissection or to generally strengthen a weakenedsection of a vessel. Stents are usually delivered to a desired locationwithin a coronary artery in a contracted condition on a balloon of acatheter which is similar in many respects to a balloon angioplastycatheter, and expanded to a larger diameter by expansion of the balloon.The balloon is deflated to remove the catheter and the stent left inplace within the artery at the site of the dilated lesion.

In the design of catheter balloons, balloon characteristics such asstrength, flexibility and compliance must be tailored to provide optimalperformance for a particular application. Angioplasty balloonspreferably have high strength for inflation at relatively high pressure,and high flexibility and softness for improved ability to track thetortuous anatomy and cross lesions. The balloon compliance is chosen sothat the balloon will have a desired amount of expansion duringinflation. Compliant balloons, for example balloons made from materialssuch as polyethylene, exhibit substantial stretching upon theapplication of tensile force. Noncompliant balloons, for exampleballoons made from materials such as PET, exhibit relatively littlestretching during inflation, and therefore provide controlled radialgrowth in response to an increase in inflation pressure within theworking pressure range. However, noncompliant balloons generally haverelatively low flexibility and softness, so that it has been difficultto provide a low compliant balloon with high flexibility and softnessfor enhanced trackability.

Therefore, what has been needed is a catheter balloon with relativelylow compliance, and with improved ability to track the patient'svasculature and cross lesions therein. The present invention satisfiesthese and other needs.

SUMMARY OF THE INVENTION

The invention is directed to a balloon catheter having a balloon formedat least in part of a blend of a first polymeric material having a firstShore durometer hardness, and at least one additional polymeric materialof essentially the same composition as the first polymeric material butcompounded to have a Shore durometer hardness less than the Shoredurometer hardness of the first polymeric material. The balloon of theinvention has enhanced softness and flexibility due to the presence ofthe second polymeric material, and a lower than expected compliance. Ina presently preferred embodiment, the balloon is formed of a blend ofpolymeric materials comprising polyether block amides.

In accordance with the invention, the balloon formed from a blend ofpolymeric materials preferably has a compliance which is notsubstantially greater than the compliance of a balloon made from 100% ofthe first polymeric material, e.g. a compliance less than about 20%greater, preferably less than 15% greater, and most preferably less than10% greater than the compliance of a balloon made from 100% of thehigher Shore durometer material. In a preferred embodiment, thecompliance of the blend is not greater than the compliance of a balloonformed of 100% of the higher Shore durometer material. Additionally, thepolymeric material blend which forms the balloon has a flexural moduluswhich is less than the flexural modulus of the first polymeric material.The softness and flexibility of a balloon is a function of the flexuralmodulus of the polymeric material of the balloon, so that a balloonmaterial having a lower Shore durometer hardness, which thus provides asoft and flexible balloon, has a lower flexural modulus. Thus, theballoon of the invention has enhanced softness and flexibility, yet doesnot have the increased compliance which would be expected from theamount of the second polymeric component having a lower Shore durometerhardness than the first polymeric component.

In one embodiment of the invention, the balloon is semi-compliant ornoncompliant. The term “noncompliant”, should be understood to mean aballoon with compliance of not greater than about 0.03millimeters/atmospheres (mm/atm). The term “semi-compliant” should beunderstood to mean a balloon with a compliance not greater than about0.045 (mm/atm). In contrast, compliant balloons typically have acompliance of greater than about 0.045 mm/atm.

The first polymeric material may range from about 10 to about 90% of theblend, and the second component of the blend may range from about 90 toabout 10%. The blend preferably has an amount of the second polymericmaterial which is greater than or equal to the amount of the firstpolymeric material. In a presently preferred embodiment, the balloon isformed of a blend of polyether block amide polymeric materials havingdifferent Shore hardness. A suitable polyether block amide copolymer foruse in the polymeric blend of the invention is PEBAX, available from ElfAtochem.

The balloon of the invention is formed by extruding a tubular productformed from the blend of the first polymeric component and at least asecond polymeric component. In a presently preferred embodiment, theballoon is formed by expanding the extruded tubular product in a balloonmold. Axial tension may be applied to the balloon during expansion, andthe balloon may be cooled under pressure and tension between blowingsteps. In one embodiment, the balloon is formed by expanding theextruded tubular product in a series of successively larger balloonmolds.

Various designs for balloon catheters well known in the art may be usedin the catheter system of the invention. For example, conventionalover-the-wire balloon catheters for angioplasty or stent deliveryusually include a guidewire receiving lumen extending the length of thecatheter shaft from a guidewire port in the proximal end of the shaft.Rapid exchange balloon catheters for similar procedures generallyinclude a short guidewire lumen extending to the distal end of the shaftfrom a guidewire port located distal to the proximal end of the shaft.

The balloon catheter of the invention has improved performance due tothe flexibility, softness, and controlled expansion of the balloon. Thepolymeric blend provides the surprising result of a balloon havingrelatively low compliance, for controlled balloon expansion, and havingrelatively high flexibility and softness, for excellent ability to trackthe patient's vasculature and cross lesions. These and other advantagesof the invention will become more apparent from the following detaileddescription of the invention and the accompanying exemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevational view partially in section of a balloon catheterwhich embodies features of the invention, showing the balloon in anunexpanded state.

FIG. 2 is a transverse cross sectional view of the balloon catheter ofFIG. 1 taken along lines 2—2.

FIG. 3 is a transverse cross sectional view of the balloon catheter ofFIG. 1 taken along lines 3—3.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates a balloon catheter which embodies features of theinvention. The catheter 10 of the invention generally comprises anelongated catheter shaft 11 having a proximal section, 12 a distalsection 13, an inflatable balloon 14 formed of a blend of polymericmaterials on the distal section 13 of the catheter shaft 11, and anadapter 17 mounted on the proximal section 12 of shaft 11. In FIG. 1,the catheter 10 is illustrated within a patient's body lumen 18, priorto expansion of the balloon 14.

In the embodiment illustrated in FIG. 1, the catheter shaft 11 has anouter tubular member 19 and an inner tubular member 20 disposed withinthe outer tubular member and defining, with the outer tubular member,inflation lumen 21. Inflation lumen 21 is in fluid communication withthe interior chamber 15 of the inflatable balloon 14. The inner tubularmember 20 has an inner lumen 22 extending therein which is configured toslidably receive a guidewire 23 suitable for advancement through apatient's coronary arteries. The distal extremity of the inflatableballoon 14 is sealingly secured to the distal extremity of the innertubular member 20 and the proximal extremity of the balloon is sealinglysecured to the distal extremity of the outer tubular member 19.

FIG. 2, showing a transverse cross section of the catheter shaft 11,illustrates the guidewire receiving lumen 22 and inflation lumen 21. Theballoon 14 can be inflated by radiopaque fluid introduced at the port inthe side arm 24 into inflation lumen 21 contained in the catheter shaft11, or by other means, such as from a passageway formed between theoutside of the catheter shaft and the member forming the balloon,depending on the particular design of the catheter. The details andmechanics of balloon inflation vary according to the specific design ofthe catheter, and are well known in the art.

Balloon 14 is formed of a blend of polymeric materials, which in apresently preferred embodiment comprises a first polyether block amidepolymeric material having a first Shore durometer hardness, and a secondpolyether block amide polymeric material having a second Shore durometerhardness less than the first Shore durometer hardness. The preferredpolymeric material for forming the polymeric blend for the balloon isPEBAX. In one embodiment, the second polymeric material, or the secondpolyether block amide polymeric material, comprises about 20% to about80%, preferably about 40% to about 75%, and most preferably about 50% toabout 60% by weight of the total weight of the blend of polymericmaterials, and the first polymeric material, or the first polyetherblock amide polymeric material, comprises about 20% to about 80%,preferably about 30% to about 70%, and most preferably about 40% toabout 50% by weight of the total weight of the blend of polymericmaterials. Most preferably, the amount of the second polymeric materialis not less than the amount of the first polymeric material. In apresently preferred embodiment, the first polyether block amidepolymeric material has a Shore durometer hardness of about 70D to about72D, and most preferably about 70D, and the second polyether block amidepolymeric material has a Shore durometer hardness of about 55D to about70D, and most preferably about 63D.

Balloon 14 of the invention preferably has a compliance which is notsubstantially greater than the compliance of a balloon consisting of thefirst polyether block amide polymeric material. Balloon 14 has acompliance of about 0.030 mm/atm to about 0.045 mm/atm, and preferablyabout 0.035, from nominal to the rated burst pressure of the balloon,where the nominal pressure is the pressure required to expand theballoon to its working diameter, and the rated burst pressure,calculated from the average rupture pressure, is the pressure at which95% of the balloons can be pressurized to without rupturing. For aballoon of the invention, having an outer diatemeter of not greater than4.0 mm, the nominal pressure is typically about 6 to about 10 atm, andthe rated burst pressure is about 14 to about 16 atm. Balloon 14 has aflexural modulus which is less than the flexural modulus of a balloonconsisting of the first polyether block amide polymeric material.Balloon 14 has a flexural modulus of about 50,000 to about 100,000 psi,and preferably about 55,000 to about 90,000 psi.

In a presently preferred embodiment, the balloon of the invention isformed by blow molding an extruded tubular product formed of a blend ofthe first and second polyether block amide polymeric materials. Theextruded tubular product is expanded to the final working diameter ofthe balloon in a balloon mold. The balloon may be heat set in the mold.In one embodiment, the balloon is blown in a series of successivelylarger balloon molds. Thus, the extruded tubular product is placed in afirst mold and the outer diameter of the tubular product is expanded atelevated pressure and temperature to a first outer diameter. The balloonis then placed in a second, larger mold, and expanded at elevatedpressure and temperature to a second outer diameter larger than thefirst outer diameter. The number of successively larger molds used toexpand the balloon may vary depending on the balloon material and size.To form a 3.0 mm outer diameter (OD) balloon, the tubular member isexpanded in a first mold to an OD of about 2.0 to about 2.5 mm, and thenexpanded in a second mold to the working diameter of 3.0 mm. Preferably,axial tension is applied to the balloon during expansion, and theballoon is cooled in the mold, under pressure and tension, betweenblowing steps. However, the balloon of the invention is preferablyproduced by conventional techniques for producing catheter inflatablemembers in which the extruded tubular product is expanded in a singlemold to the working diameter.

The balloon 14 has sufficient strength to withstand the inflationpressures needed to inflate the balloon. Balloon 14 formed from a blendof the invention preferably has a burst pressure which is notsubstantially less than the burst pressure of a balloon made from 100%of the first polymeric material, i.e., a burst pressure not more thanabout 15% to about 20% less than, preferably not more than 5% to about15% less than the burst pressure of a balloon made from 100% of thefirst polymeric material. In a preferred embodiment, the burst pressureof balloon 14 is not less than the burst pressure of a balloon formed of100% of the first polymeric material. The average burst pressure ofballoon 14, having an outer diameter of about 3.0 mm, a length of about20 mm and a dual wall thickness of about 0.036 mm is about 18 atm toabout 26 atm. This compares well with the average burst pressure of 18atm to 26 atm for 3.0 mm balloons blown from 100% of the first polymericmaterial. The tensile strength of an American Standard Testing Method(ASTM) “dog-bone” sample cut from a compression molded sheet of materialis about 8,000 psi to about 9,000 psi. The hoop strength, e.g. theproduct of the burst pressure and the balloon diameter, divided by twotimes the balloon wall thickness, of a 3.0 mm balloon of the inventionis about 22,000 psi to about 32,000 psi.

The catheter shaft will generally have the dimensions of conventionaldilatation or stent deploying catheters. The length of the catheter 10may be about 90 cm to about 150 cm, and is typically about 135 cm. Theouter tubular member 19 has a length of about 25 cm to about 40 cm, anouter diameter (OD) of about 0.039 in to about 0.042 in, and an innerdiameter (ID) of about 0.032 in. The inner tubular member 20 has alength of about 25 cm to about 40 cm, an OD of about 0.024 in and an IDof about 0.018 in. The inner and outer tubular members may taper in thedistal section to a smaller OD or ID.

The length of the compliant balloon 14 may be about 1 cm to about 4 cm,preferably about 0.8 cm to about 4.0 cm, and is typically about 2.0 cm.In an expanded state, at nominal pressure of about 8 to about 10 atm,the balloon diameter is generally about 0.06 in (1.5 mm) to about 0.20in (5.0 mm). and the wall thickness is about 0.0006 in (0.015 mm) toabout 0.001 in (0.025 mm), or a dual wall thickness of about 0.025 mm toabout 0.056 mm. The burst pressure is typically about 18 to 26 atm, andthe rated burst pressure is typically about 14 atm.

In a presently preferred embodiment, the balloon 14 typically formswings, which may be folded into a low profile configuration (not shown)for introduction into and advancement within the patient's vasculature.When inflating the balloon to dilate a stenosis, the catheter 10 isinserted into a patient's vasculature to the desired location, andinflation fluid is delivered through the inflation lumen 21 to theballoon 14 through the inflation port 24. The semi-compliant ornoncompliant balloon 14 expands in a controlled fashion with limitedradial expansion, to increase the size of the passageway through thestenosed region. Similarly, the balloon has low axial growth duringinflation, to a rated burst pressure of about 14 atm, of about 5 toabout 10%. The balloon is then deflated to allow the catheter to bewithdrawn. The balloon may be used to deliver a stent (not shown), whichmay be any of a variety of stent materials and forms designed to beimplanted by an expanding member, see for example U.S. Pat. No.5,514,154 (Lau et al.) and U.S. Pat. No. 5,443,500 (Sigwart),incorporated herein in their entireties by reference.

EXAMPLE 1

Polymeric blends were formed using PEBAX 7033 SA01 and PEBAX 6333 SA01.PEBAX 7033 (hereafter “PEBAX 70D”) has a Shore durometer hardness ofabout 70D, a flexural modulus of 67,000 psi, and tensile strength of8300 psi. PEBAX 6333 (hereafter PEBAX 63D) has a Shore durometerhardness of about 63D, a flexural modulus of 49,000 psi, and a tensilestrength of 8100 psi. PEBAX 70D was blended with PEBAX 63D, where thePEBAX 70D was 40% by weight of the total blend and the PEBAX 63D was 60%by weight of the total blend. The blend was used to prepare 15 samplesof balloon tubing having a mean ID of about 0.018 inch (0.46 mm) and amean OD of about 0.034 inch (0.86 mm), with a blow up ratio of 6.6. Theballoon tubing may be necked in a die before expanding the balloontubing in a mold to form the balloon. A balloon was formed from theballoon tubing by axially stretching the balloon tubing at elevatedtemperature, and expanding the balloon tubing in a balloon mold whileheating the balloon tubing by traversing the length of the mold with aheated air nozzel (at about 360° F. to about 420° F. temperaturecontroller set temperature) at a rate of about 1 mm/sec to about 25mm/sec, and pressurizing the balloon at about 250 psi to about 450 psito an OD of 3.0 mm (for a blow up ratio of about 6.6). The balloon wasthen heat treated in the mold by traversing the length of the mold witha second heated air nozzel, for about 5 to about 30 seconds (at about220° F. to about 300° F. temperature controller set temperature). Theballoon was cooled in the mold. The balloons have an OD of about 3.0 mm,a length of 20 mm, and a mean single wall thickness of about 0.00065inch (0.017 mm) to about 0.00080 inch (0.02 mm). The mean rupturepressure of the balloons was about 20 atm. Radial (OD) compliancemeasurements made on the blown balloons show a compliance of about 0.036mm/atm from a nominal OD of about 3.0 mm at about 8 atm to an outerdiameter of about 3.25 mm at about 15 atm. Table 1 lists the averageballoon OD for the unruptured balloons, at a given inflation pressure.

TABLE 1 Inflation Pressure Average Balloon (psi)/(atm) OD (mm) 30/22.603 45/3 2.759 60/4 2.831 75/5 2.887 90/6 2.933 105/7 2.971 120/83.004 135/9 3.038 150/10 3.070 165/11 3.102 180/12 3.132 195/13 3.166210/14 3.202 225/15 3.235 240/16 3.273 255/17 3.315 270/18 3.350 285/193.397 300/20 3.454

EXAMPLE 2

PEBAX 70D was blended with PEBAX 63D, where the PEBAX 70D was 40% byweight of the total blend and the PEBAX 63D was 60% by weight of thetotal blend. The blend was used to prepare balloon tubing having an IDof about 0.0195 inch (0.495 mm) and an OD of about 0.0355 inch (0.902mm), which was used to prepare balloons having a single wall thicknessof about 0.00065 (0.017 mm) to about 0.0008 inch (0.02 mm), with a blowup ratio of about 6.0, using a procedure similar to the procedureoutlined in Example 1, except that the same heated air nozzel that wasused to heat the balloon tubing during the expansion of the balloontubing in the mold was used to heat treat the entire length of theballoon within the mold after the balloon tubing is expanded in themold. Similarly, a second balloon was formed from 100% PEBAX 70D.

Radial (OD) compliance and rupture pressure measurement were made onblown balloons, as listed below in Table 2. The compliance was measuredfrom 8 atm (nominal OD of 3.0) to 14 atm (OD of about 3.25 mm). Theballoons formed from a blend of PEBAX 70D and PEBAX 63D had complianceequal to the balloon formed from 100% PEBAX 70D.

TABLE 2 PEBAX PEBAX 70D 70D/63D 100% 40%/60% COMPLIANCE 0.042 0.042(mm/atm) n = 15 MEAN RUPTURE 294 294 PRESSURE (psi) n = 15

EXAMPLE 3

A first balloon was formed from a blend of 60 weight % PEBAX 70D and 40weight % PEBAX 63D. The blend was used to prepare balloon tubing havingan ID of about 0.019 inch (0.495 mm) and an OD of about 0.0355 inch(0.902 mm), and a balloon was formed from the balloon tubing by axiallystretching and expanding the balloon tubing in a first mold at 370 psiand 235° C. (temperature controller set temperature) to an OD of 2.0 mm,cooling the balloon in the mold at the elevated pressure, expanding theballoon in a second mold at 370 psi and 237° C. (temperature controllerset temperature) to an OD of 3.0 mm and a length of 20 mm, and coolingthe balloon in the mold at the elevated pressure. Similarly, a secondballoon was formed from a blend of 80 weight % PEBAX 70D and 20 weight %PEBAX 63D, and a third balloon was formed from 100% PEBAX 63D.

Radial (OD) compliance and rupture pressure measurement were made onblown balloons, as listed below in Table 3. The compliance was measuredfrom a nominal pressure required to expand to an OD of about 3.0(typically about 6–8 atm) to the pressure required to expand the balloonto an OD of approximately 3.25 mm (typically about 11–16 atm). Theballoons formed from a blend of 60 weight % PEBAX 70D and 40 weight %PEBAX 63D, despite the higher weight % of the higher Shore durometerPEBAX polymeric material, had substantially similar rupture pressure andcompliance compared to the balloons formed from 80 weight % PEBAX 70Dand 20 weight % PEBAX 63D. Specifically, the balloons formed of a 60/40blend had lower rupture pressure and higher compliance than the balloonsformed of a 80/20 blend.

TABLE 3 PEBAX PEBAX PEBAX 70D/63D 70D/63D 63D 80%/20% 60%/40% 100%COMPLIANCE 0.0304 0.0353 0.049 (mm/atm) MEAN RUPTURE 311 294 260PRESSURE (psi) n = 10 AXIAL GROWTH 1.4 1.56 1.98 (mm) DUAL WALL 0.0380.037 0.042 THICKNESS (mm) The compliance data for baloons is givenbelow in Tables 4–6.

TABLE 4 PEBAX 70D/63D:80%/20% Inflation Pressure Average Balloon(psi)/(atm) OD (mm) 30/2 2.721 45/3 2.777 60/4 2.834 75/5 2.882 90/62.930 105/7 2.965 120/8 2.997 135/9 3.027 150/10 3.056 165/11 3.085180/12 3.114 195/13 3.147 210/14 3.181 225/15 3.217 240/16 3.256 255/173.299 270/18 3.347 285/19 3.403 300/20 3.475

TABLE 5 PEBAX 70D/63D:60%/40% Inflation Pressure Average Balloon(psi)/(atm) OD (mm) (n = 10) 30/2 2.722 45/3 2.788 60/4 2.849 75/5 2.90490/6 2.943 105/7 2.982 120/8 3.016 135/9 3.048 150/10 3.082 165/11 3.114180/12 3.150 195/13 3.191 210/14 3.228 225/15 3.273 240/16 3.319 255/173.372 270/18 3.441 285/19 3.525 300/20 3.628

TABLE 6 PEBAX 70D/63D:100% 63D Inflation Pressure Average Balloon(psi)/(atm) OD (mm) (n = 10) 30/2 2.784 45/3 2.864 60/4 2.931 75/5 2.98290/6 3.024 105/7 3.063 120/8 3.102 135/9 3.143 150/10 3.190 165/11 3.242180/12 3.300 195/13 3.360 210/14 3.415 225/15 3.464 240/16 3.541 255/173.639 270/18 3.766

EXAMPLE 4

Blends of PEBAX 70D and PEBAX 63D were used to form extruded tubinghaving an ID of 0.0328 inch and an OD of 0.0568 inch. Flexural modulusmeasurements were made on the extruded tubing using a three point bendtest. The average flexural modulus from a sample of 6 specimens was 15.7gram/mm for the PEBAX 70D 100% formulation, and was 14.4 gram/mm for thePEBAX 70D/63D 80%/20% formulation, and was 11.5 for the PEBAX 70D/63D40%/60% formulation. Thus, increasing the weight percent of the lowerShore durometer material (i.e., PEBAX 63D) did increase the flexibilityof the extruded tubing.

It will be apparent from the foregoing that, while particular forms ofthe invention have been illustrated and described, various modificationscan be made without departing from the spirit and scope of theinvention. For example, while the balloon is discussed primarily interms of a blend of polyether block amides, it should be understood thatother blends which have the desired characteristics outlined above mayalso be used. Although individual features of embodiments of theinvention may be described or shown in some of the drawings and not inothers, those skilled in the art will recognize that individual featuresof one embodiment of the invention can be combined with any or all thefeatures of another embodiment. Other modifications may be made withoutdeparting from the scope of the invention.

1. A balloon catheter, comprising a) a shaft having a proximal end, adistal end, and an inflation lumen extending therein; and b) a balloonon the shaft which has an interior in fluid communication with theinflation lumen, and which is formed of a blend of polymeric materialscomprising a first polyether block amide polymeric material having afirst Shore durometer hardness of about 60D to about 72D and being notmore than about 50% by weight of the blend, and a second polyether blocka mide polymeric material having a second Shore durometer hardness ofabout 55D to about 70D and less than the first Shore durometer hardness,and the balloon having a rupture pressure not substantially less than aballoon consisting of the first polyether block amide polymericmaterial.
 2. The balloon catheter of claim 1 wherein the balloon has acompliance which is not substantially greater than a compliance of aballoon consisting of the first polyether block amide polymericmaterial.
 3. The balloon catheter of claim 1 wherein the balloon has acompliance which is not greater than a compliance of a balloonconsisting of the first polyether block amide polymeric material.
 4. Theballoon catheter of claim 1 wherein the blend has a flexural moduluslower than a flexural modulus of the first polyether block amidepolymeric material.
 5. The balloon catheter of claim 1 wherein theballoon mean rupture pressure is equal to a mean rupture pressure of aballoon consisting of the first polyether block amide polymericmaterial.
 6. The balloon catheter of claim 1 wherein the first polyetherblock amide polymeric material is about 40% by weight of the blend, andthe second polyether block amide polymeric material is about 60% byweight of the blend.
 7. The balloon of claim 1 wherein the secondpolyether block amide polymeric material comprises about 40% to about60% by weight of the total blend.
 8. The catheter balloon of claim 1wherein the first polyether block amide polymeric material comprisesabout 40% to about 50% by weight of the total blend.
 9. The ballooncatheter of claim 1 wherein the first polyether block amide polymericmaterial has a Shore durometer hardness of about 70D.
 10. The ballooncatheter of claim 1 wherein the second polyether block amide polymericmaterial has a Shore durometer hardness of about 63D.
 11. The ballooncatheter of claim 1 wherein the balloon has a compliance of not greaterthan about 0.045 mm/atm from a nominal to a rated burst pressure of theballoon.
 12. The balloon catheter of claim 1 wherein the balloon has acompliance of about 0.03 mm/atm to about 0.035 mm/atm from a nominal toa rated burst pressure of the balloon.
 13. The balloon of claim 1wherein the balloon has a flexural modulus which is less than a flexuralmodulus of a balloon consisting of the first polyether block amidepolymeric material.
 14. The balloon catheter of claim 13 wherein theballoon has a flexural modulus which is about 10% to about 36% less thana flexural modulus of a balloon consisting of the first polyether blockamide polymeric material.
 15. The balloon catheter of claim 1 whereinthe balloon has a dual wall thickness of about 0.025 to about 0.056 mm,and a nominal outer diameter of about 1.5 to about 5.0 mm.
 16. Theballoon catheter of claim 1 wherein the balloon rupture pressure is notmore than about 5% to about 15% less than the burst pressure of theballoon consisting of the first polyether block amide polymericmaterial.
 17. A balloon catheter, comprising a) an elongated shafthaving a proximal end, a distal end, and at least one lumen therein; andb) a balloon formed at least in part of a blend of a first polyetherblock amide polymeric material having a first Shore durometer hardnessof about 70D, and being about 40% to about 50% by weight of the totalblend; and a second polyether block amide polymeric material having asecond Shore durometer hardness which is less than the Shore durometerhardness first polyether block amide polymeric material and which isabout 63D, being about 50% to about 60% by weight of the total blend,and the balloon having a rupture pressure not substantially less than aballoon consisting of the first polyether block amide polymericmaterial.
 18. The balloon catheter of claim 1 wherein the balloon has acompliance of not greater than about 0.045 mm/atm over a pressure rangeof about 8 atm to about 14 atm.